Ifosfamide, cisplatin and etoposide combination in locally advanced inoperable non-small cell lung cancer: a phase II study

From March 1993 to February 1997, 43 eligible patients with inoperable stag e IIIA (ten patients) and stage IIIB (33 patients), histologically confirme d NSCLC received 3 courses of the ICE combination (ifosfamide 1.5 g m(-2) a nd mesna 750 mg m(-2) two times a day, cisplatin 25 mg m(-2) and etoposide 100 mg m(-2), all administered intravenously (i.v.) on days 1-3 every 3 wee ks) with G-GSF support. After three cycles, patients were submitted to radi cal surgery or received two additional courses of the ICE regimen and/or cu rative radiotherapy. Grade 3-4 neutropenia occurred in 21% of 114 evaluable courses, but was of short duration, leading to neutropenic fever in 5% of the courses. Severe thrombocytopenia and anaemia were observed in 13% and 3 % of the courses respectively. Non-haematological toxicity was generally mi ld with only two episodes of reversible renal impairment. The overall respo nse rate after three chemotherapy courses was 69% (28 partial responses, on e complete response). Ten patients (8/10 patients in stage IIIA, 2/33 patie nts in stage IIIB) underwent radical surgery. Median TTP for patients not u ndergoing surgery (n = 33) was 8 months (range 3-34+); median DFS for patie nts rendered NED by surgery (n = 10) was 26 months (range 1-54+). Median OS for the entire group was 12.5 months (range 2-57+). The ICE regimen is act ive in locally advanced NSCLC with acceptable toxicity and warrants further exploration as induction chemotherapy in larger series. (C) 1999 Cancer Re search Campaign.